You are here

Evaluating the efficacy of Topiramate in preventing migraine in patients aged below 18 years

Primary tabs

Evaluating the efficacy of Topiramate in preventing migraine in patients aged below 18 years

Key Take-Away:

Topiramate might not be helpful in achieving a more efficient clinical trial endpoint than placebo in preventing migraine in patients less than 18 years of age.

Migraine is one of the most popular causes of a headache prevalent in pediatric neurology patients. It affects about 5-10% of children at various stages of life. It impairs daily life activities of patients like presence in school, social events, and friendship.

ABSTRACT:

Background:

Migraine is one of the most popular causes of a headache prevalent in pediatric neurology patients. It affects about 5-10% of children at various stages of life. It impairs daily life activities of patients like presence in school, social events, and friendship. Also, it disturbs the family harmony and self-esteem of the individual. The onset of migraine occurs in 7.2 years in boys and 10.9 years in girls and increases with age.

The diagnostic criteria for migraine headache has emerged over time, and modern classification criteria include frequency as a criterion. Episodic headaches is defined as headache occurring up to 14 days per month, while chronic migraine refers to the persistence of headache without aura for at least 15 days per month and at least 3 consecutive months without medication overuse (ICHD-II). There always exists a diversity of symptoms, so diagnostic criteria for migraine in children needs to be refined further.

A variety of prophylactic treatments are available to reduce the severity of headaches. Topiramate is an antiepileptic drug that exhibits favorable efficacy and safety in children and adults with epilepsy. It has been approved for preventing migraine in adults in Europe since 2003 and the United States since 2004. The mechanism of action of Topiramate in migraine is still unknown, but it was found to be related with influence on pain transmission in the trigeminocervical complex and the third-order neurons in the ventroposteromedial thalamus. Several studies have reported the efficacy of Topiramate in pediatric populations with severe headache and migraine, but a study conducted by Scott W et al determined that there were no significant differences between Topiramate and placebo in the prevention of migraine.

Rationale behind the research

There is lack of clarity regarding the efficacy of Topiramate in the pediatric population. So, a meta-analysis of randomized controlled trials (RCTs) was conducted to evaluate the effectiveness of Topiramate in migraine prevention in patients aged below 18 years.

Objective

To assess the currently published data about the efficacy of Topiramate for migraine prevention in patients aged below 18 years.

In this meta-analysis, the efficacy of Topiramate in comparison with placebo for the prevention of migraines in patients aged below 18 years was examined. As indicated by IHS guidelines, the reduction in the total number of headache attacks in a 28-day period or the proportion of patients with a higher than 50% relative reduction in headache frequency defines the efficacy of Topiramate in comparison with placebo in the prevention of migraine in patients aged <18 years.

The first finding of the study indicates that there were no significant differences between Topiramate and placebo group in reducing 50% headache frequency and reduced mean headache days in a 28-day period. Three explanations were made for these possible outcomes: 1) High response rate to placebo in children and younger patients (age-related response 30-70%). 2) Difficult to monitor headache changes in children aged 8-12 years due to the incorrect interpretation made by parents. 3) Patients with either episodic or chronic migraine were included which may influence the results of the meta-analysis. The second finding of the study indicated a decrease in PedMIDAS scores on administration with Topiramate. This contradicts that headache-related disability can be alleviated by Topiramate administration. Mean PedMIDAS scores in both the Topiramate group and the placebo group decreased between baseline and endpoint, and the fact that only two trials used this tool as a trial assessment may be the cause of the heterogeneity.

It was evaluated that Topiramate has various side effects which may be serious and life-threatening as compared to placebo. The various adverse effects reported in previous studies were metabolic acidosis, renal calculi, nervous system effects, such as fatigue or somnolence, dizziness, cognitive disorder or aphasia. Other adverse effects reported in this meta-analysis were changes in visual acuity, including visual field deficits, acute myopia, and secondary closed-angle glaucoma. Topiramate also increases the psychomotor reaction times and sometimes suicidal behavior and ideation in some patients. Overall, it was concluded that pathomechanism of migraine is not entirely understood, the choice of medication for personalized therapy tailored to each patient needs to be made cautiously.

The data had obvious heterogeneity, and none of the variables in this study had explained this variation.

Incomplete reporting of intervention intensity was also one of the limitations of this study.

Clinical Take-Away:

Topiramate did not found to be effective than placebo in preventing migraine in patients <18 years of age.

About

Medznat, an initiative of Dr. Reddy’s Laboratories Ltd., is a resource for practicing doctors to enable their continuous learning. It provides unbiased and relevant medical information, apart from several other useful resources to aid their daily practice.

Medznat brings together premium content from leading publishers globally, to deliver comprehensive and up-to-date medical information.

Content Source

Medznat presents current medical information from the world's leading sources - the largest databases PubMed and DOAJ. Translation of articles made by ABBYY-LS

The scientific editors of the Medznat website make sure that our publications are accurate, simple and useful to the readers. We are always glad for your questions or suggestions!

Dr. Reddy’s Laboratories Ltd. dose not endores and its not responsible for the accuracy of the content, or for practices or standards of Dr. Reddy’s Laboratories Ltd sources. Please read our Terms of Use for more information